The European Medicines Agency’s Updated Guidelines for JAK Inhibitors in Rheumatoid Arthritis – A Cause for Concern? Spherix Investigates

On October 28, 2022, the European Medicines Agency’s (EMA) safety committee (PRAC) announced recommendations to minimize the risk of serious side effects when using JAK inhibitors to treat chronic inflammatory disorders. Spherix collected immediate reactions, opinions, and potential impacts of this news through their RealTime Dynamix™ research series, which surveyed approximately 271 rheumatologists across the EU5 countries (France, Germany, Italy, Spain, and the United Kingdom).

When prompted, nearly three-quarters of EU5 rheumatologists were aware of the EMA’s guidance on avoiding use of JAK inhibitors in certain patient segments, including those that are 65 years or older, have increased risk of MACE, are current smokers/have a history of smoking, or those with increased risk of cancer.

The majority of respondents reported that the update will have a negative impact on their opinion of all JAK inhibitors with respect to their use in rheumatoid arthritis (RA), though perceptions of Pfizer’s Xeljanz are far more pessimistic than those of Eli Lilly’s Olumiant, AbbVie’s Rinvoq, or Galapagos’ Jyseleca. Despite this, over half of respondents agreed they have concerns about the risk of MACE and malignancies when using any JAK inhibitor – not just Xeljanz.

EU5 physicians expect the new guidelines to affect approximately two-fifths of their RA patients, regardless of whether they possess risk factors or not. Although there is a large concern regarding use in all RA patients, those who are currently treated with a JAK inhibitor and have at least one risk factor are more likely to be switched to another agent in the next three months compared to those who are not at risk. On a more positive note, about one-quarter of respondents indicated they will try lowering the dosage for at-risk patients first before switching to another agent – a metric that was consistent for all JAK brands captured in the study.

Despite the negative connotations this new label has brought upon the JAK class and its impact on certain patient groups in the EU5, prescribing over the next six months does not appear to be impacted overall. In fact, market share for Xeljanz and Olumiant are expected to remain stable, while Rinvoq and Jyseleca are anticipated to continue growing.

The EMA’s recommended guidelines for the use of JAK inhibitors is currently having a greater impact on the perceptions of these agents, rather than rheumatologists’ current and future intended prescribing. This can likely be attributed to the fact that rheumatologists have already known many of the associated risks and have found many benefits to the use of these drugs prior to this news. Spherix will continue to follow the evolving EU market and assess whether physician intentions match up to actual prescribing behavior through their patient chart audits.About RealTime Dynamix™

RealTime Dynamix™ is an independent study service by Spherix Global Insights that provides strategic guidance through quarterly or semiannual reports. These reports include market trending and a fresh infusion of event-driven and variable content with each quarterly wave. These reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of industry acclaimed subject matter experts.About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry.

The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.

A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology and ophthalmology.

To learn more about Spherix Global Insights, visit or connect through LinkedIn and Twitter.Spherix Global Insights Contact:

Emily Hettel, Associate Insights Director, Rheumatology
[email protected]

Scott Upham, Corporate Communications
[email protected]

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SOURCE Spherix Global Insights

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